activL® Artificial Lumbar Disc Replacement

Who should be treated with the activL® Artificial Disc?

The activL® Artificial Disc may be considered in patients who:

  • Are skeletally mature (have vertebrae that are fully formed and grown)
  • Have low back pain with or without leg pain due to a problem with one (1) degenerated lumbar disc at either the L4-L5 level or L5-S1 level (as determined by Dr. Idema).
  • May have neurological symptoms such as weakness or numbness if the damaged disc is irritated the nerve roots (radiculopathy)
  • Have proven disc degeneration at only one lumbar disc level L4-L5 or L5-S1 and have been diagnosed as having DDD at that level as confirmed by Dr. Idema’s review of your medical history, physical examination, and medical images.
  • Have gone through at least six (6) months of non-surgical treatment without relief.
Who should NOT be treated with the activL® Artificial Disc? (Contraindications)

If you have any of the following conditions, you should not have surgery with the activL® Artificial Disc:

  • Active whole body (systemic) infection(s) such as pneumonia, UTI, or other infections near the surgical site because undergoing surgery could interfere with your ability to heal and could increase the chance of spreading or worsening the infection.
  • Osteoporosis or osteopenia (thinning or weak bones) – these conditions could increase the risk of your bones breaking or could cause the implant to loosen.
  • Allergy or sensitivity to the materials that make up the activL® Artificial Disc (cobalt, chromium, polyethylene, titanium, tantalum, or calcium phosphate).  Please notify Dr. Idema if you have a metal allergy because use of the activL® Artificial Disc could cause can allergic reaction.
  • Leg pain caused by a single nerve root compression “pinched nerve” because your pain may be better treated with a different surgical procedure.
  • Narrowing of the spinal canal (stenosis), nerve root damage (chronic radiculopathy), disc fragment that has separated and moved from the disc space, or spinal deformity such as scoliosis because surgery with the activL® Artificial Disc may not be able to treat your symptoms.
  • Too much forward slippage of your upper vertebrae with respect to your lower vertebrae (spondylolisthesis > grade 1) or a fracture in a specific location in your vertebrae (referred to as a pars defect) as determined by Dr. Idema with could in turn cause additional instability of your spine.
  • A lumbar spine that shows an unhealthy amount of extra movement (instability) on X-rays because the activL® Artificial Disc may not provide enough stability.
  • Damaged lumbar vertebrae due to an accident (trauma) or disease (including inflammatory diseases where the vertebrae swell or grow together and limit movement such as anklyosing spondylitis and rheumatoid arthritis).  Use of the activL® Artificial Disc is these situations may lead to poor performance of the implant.
  • Severe disease or degeneration in the joints in the back of your spine (facet joints) as determined by Dr. Idema because surgery with the activL® Artificial Disc will not treat this.
  • Too little space remaining between the vertebrae because the disc has collapsed too much.  In these cases, the activL® Artificial Disc will not be able to function properly.
  • Disc degeneration requiring treatment at more than one level as the activL® Artificial Disc has only been evaluated in patients with one lumbar disc requiring treatment.
  • Existing conditions that would make surgery through the belly impossible.
WARNINGS
Possible Dangers

Implanting an artificial disc in the spine is serious surgery.  There are blood vessels and nerves very close to where the implants enter the body.  Dr. Idema will take great care to find and protect the blood vessels and nerves.

Potential Consequences include:

  • A small cut to a blood vessel could cause dangerous or even fatal loss of blood (hemorrhage).
  • Damage to a nerve could cause long-term loss of movement (paralysis) or feeling (sensation).
Possible Complications

As with any artificial disc surgery, there are steps that the Center for Disc Replacement Surgery at AOR has taken to ensure that your surgery is safe:

  • The Center for Disc Replacement Surgery at AOR has highly-skilled expert spine surgeons with Dr. Idema.
  • Dr. Idema has been specifically trained and is certified in the proper use of the activL® Artificial Disc which includes the proper candidate, how it works, how to choose the correct size, and how to implant it correctly.
  • If you choose a surgeon that does not have enough experience or training, you run the risk and higher chance of problems during and after your surgery.

Bone could grow outside of the vertebrae (heterotopic ossification [HO]).  HO can happen after lumbar artificial disc surgery and may cause less lumbar motion due to bone build-up.

  • If HO forms, the potential consequences are not fully understood.

What are the WARNINGS and PRECAUTIONS associated with using the activL® Artificial Disc?

There was a clinical trial in the United States to evaluate patients treated with the activL® Artificial Disc.  To participate in the clinical trial, patients had to meet certain criteria.  For example, patients could not be included in the trail if they were older than 60 years, if they had undergone previous lower back surgery, or if they were taking steroids.  As a result, it is unknown at this time if the activL® Artificial Disc will perform as well in the other types of patients compared to those included in the trial.  Take the time to understand the possible dangers from lumbar artificial disc replacement surgery.

Talk to Dr. Idema and the staff at the Centers for Disc Replacement Surgery at AOR about the possible dangers and complications of the activL® Artificial Disc surgery.

PRECAUTIONS

Because the clinical trial only evaluated patients who met certain criteria, the safety and effectiveness of the activL® Artificial Disc has not been tested in patients with the following conditions:

  • More than one lumbar spine level that is damaged and needs surgery
  • The young (younger than 18) and the elderly (older than 60)
  • Patients whose bones are still growing
  • Previous lumbar spine surgery
  • Back or leg pain from an unknown source
  • Disease of the bone caused by low mineral levels or genetic problems (Paget’s Disease, Osteomalacia, or other metabolic bone diseases)
  • Very overweight/obese (BMI greater than 35 based on NIH Clinical Guidelines)
  • Pregnancy
  • Taking medicine that is known to get in the way of bone or soft tissue healing (such as steroids)
  • Diseases that cause the vertebrae to swell or grow together and limit movement, such as Rheumatoid Arthritis, Lupus, or other Autoimmune Diseases)
  • Whole body (systemic) diseases, including AIDS, HIV, and hepatitis
  • Active Cancer (malignancy)
  • Diseases that affect muscle movement because of problems with nerves or muscles (neuromuscular disorders).  Examples include: Parkinson’s Disease, Amyotrophic Lateral Sclerosis (ALS), or Multiple Sclerosis.
  • Serious mental illness or drug abuse.
  • Insulin dependent diabetes
An Up-To-Date Medical History is VERY important on whether the activL® Artificial Disc is right for you.

Careful consideration will be evaluated on:

  • Your job and activity level
  • Your current and past mental and physical health
  • Alcoholism or drug abuse
  • Medicine use
  • Previous treatments and surgeries

You may be asked questions to help better decide if you have risk of low bone mineral density.  Based on your answers, Dr. Idema may order a bone test (DEXA measurement).  The activL® Artificial Disc has not been tested in patients with a spinal DEXA “T-Score” less than or equal to -1.0 (who may have osteoporosis or osteopenia).

A correctly sized activL® Artificial Disc is important so that the implant stays in place and works right for you.  Dr. Idema will not start surgery without the right implant size or instruments that are in good working order.  This implant is placed close to major blood vessels and nerves.  There is a risk of nerve damage and/or serious or fatal bleeding if these structures are damaged during surgery.

Dr. Idema will talk to you about all of the risks and complications associated with the activL® Artificial Disc and give you plenty of time to ask questions.  You can also ask to see the full list of precautions and risks/complications which are listed in the activL® Artificial Disc insert.

**It is extremely important that you let Dr. Idema and her team know about any medications you are taking, any allergies you have, if you are pregnant, may become pregnant, or if you have any other illnesses or medical conditions that may help Dr. Idema and her team decide if this implant is right for you.  Failure to fully inform Dr. Idema and her team about your overall state of health and existing medical conditions may create unnecessary complications if you are treated with this implant.  It is also very important that you carefully follow Dr. Idema’s instructions after surgery.  Extreme activities like lifting very heavy weights may result in failure of your implant.

What are the potential RISKS and ADVERSE EFFECTS associated with using the activL® Artificial Disc?

Complications may occur when you are treated with the activL® Artificial Disc, as with any surgery.  Although many of the major risks are covered in the the activL® Artificial Disc patient information list, a full list is provided in the package insert for the implant, which your doctor has received.  Please ask Dr. Idema and her team for more information about any additional risks that could be related to your planned surgery.

Possible complications may include, but are not limited to the following:

Risks associated with low back surgery:
  • Injury to the surrounding organs and structures including nerves, surrounding spinal bones, structures that carry lymph (lymphatic vessels), blood vessels, soft tissue, the membrane that surrounds the spinal cord (dura), intestines, kidneys, and ureters.
  • Problems controlling your bowel or bladder function.
  • Sexual and reproductive problems including ejaculation of semen into the bladder (retrograde ejaculation)
  • Muscle weakness or loss of movement (paralysis)
  • Numbness or tingling
  • Back or leg pain
  • Swelling from a mass of clotted blood inside the spinal canal (epidural hematoma) or in the region next to where the abdominal organs are located (retroperitoneal hematoma)
  • Scarring in the belly (adhesions)
  • Weakness in the belly muscles (hernia)
  • Swelling or infection in the outside cover of the spinal cord or brain (meningitis)
Risks associated with any surgery: